EUCTR2012-004952-12-DE进行中（未招募）1 期
A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) with Placebo for the Treatment of Geographic Atrophy Associated with Dry Age-Related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Acucela Inc.
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males or females, age =55 years.
- •2. Clinical diagnosis of GA associated with AMD in 1 or both eyes as determined by the Investigator and confirmed by the reading center.
- •3. The study eye must meet the following criteria as determined by the central reading center’s assessment of fundus autofluorescence (FAF) imaging at screening:
- •a. Total area of GA =1.25 - 18 square mm (~0.5 - 7 disc areas) in size.
- •b. If GA is multifocal, at least 1 locus of GA must be =1.25 mm2 (0.5 disc area) in size, with the overall aggregate area of GA, within the vascular arcades, =18 mm2 (~7 disc areas).
- •c. The entire lesion must be completely visualized on the macula-centered image (Field 2 –Macula Image). GA must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
- •4. Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA of =35 letters (approximately =20/200 Snellen) in the study eye.
- •5. Adequate clarity of ocular media and adequate pupillary dilation to permit good quality imaging of GA in the study eye as determined by the Investigator.
- •6. Able and willing to provide written informed consent before undergoing any study-related procedures.
- •7. Able to reliably administer oral medication by self or with available assistance.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 432
排除标准
- •1. History of, active or high risk of developing CNV:
- •a. History of CNV associated with AMD in the study eye
- •b. Active CNV in the study eye as confirmed by the central reading center
- •c. Or a spherical equivalent >8 diopters of myopia in refractive error in either eye. If the subject has previously undergone refractive surgery, including cataract surgery, then the pre-operative error cannot be >8 diopters of myopia.
- •Note: CNV associated with AMD in the non-study eye is allowed regardless of treatment status.
- •2. Geographic atrophy associated with a condition other than AMD in either eye, or macular GA with contiguous area of peripapillary atrophy in the study eye.
- •3. Presence in either eye of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function, including, but not limited to, uveitis, other macular diseases or uncontrolled glaucoma/ocular hypertension (=25 mm Hg with or without glaucoma
- •medication treatment).
- •4. History in study eye of macular edema, ext. beam radiat., macular surgery, or transpup. thermotherapy.
- •5. History of any intraocular or ocular surface surgery in either eye within 3 months of screen..
- •6. Prev. particip. in an investigat. study of ACU-4429.
- •7. Known serious allergy to fluorescein sodium for injection in angiography or hypersensitivity to ACU-4429 or any of the excipients in ACU-4429 tablets (ie, silicif. microcrystall. cellulose, pregelatin. starch, coll. silicon dioxide and stearic acid).
- •8. Prohibited medications: Use of a strong inhibitor or inducer of cytochrome P450 enzyme CYP3A4 or a strong inducer of or a strong or moderate inhibitor of CYP2D6 (as listed in Appendix B) beginning 4 weeks prior to screening and throughout the duration of the study period.
- •9. [please see protocol]
- •10. Change in a systemic prescription medication or a medication newly prescribed within 30 days prior to screening and between screening and baseline.
- •11. Participation during the study period in any study using an investigational study drug (within 30 days of screening) or interventional device (within 60 days of screening). Age-related Eye Disease Study (AREDS)-formulated vitamins (which have been under investigation) are allowed during the study period.
- •12. History of other disease, metabolic dysfunction, chronic immunosuppression, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator gives reasonable suspicion of a disease or condition which contraindicates the use of an investigational drug or might have affected interpretation of the results of the study or rendered the subject at high risk for treatment complications.
- •13. Current or history of cancer (except non-metastatic in situ or well-controlled carcinoma, [eg, basal cell carcinoma]) within 1 year of screening.
- •14. Any medical condition (eg, malabsorption, inflammatory bowel disease, or hepatic or renal disease) that could alter the absorption, metabolism, or elimination of drugs.
- •15. History of myocardial infarction, stroke, unstable ischemic heart disease, uncontrolled cardiac arrhythmia, or hospitalization for congestive heart failure within 6 months of screening.
- •16. Abnormal electrocardiogram (ECG) results that are considered by the Investigator to be clinically significant at screening.
- •17. Female subjects who are pregnant or lactating.
- •18. Female subjects of childbearing potential (ie, not postmenopausal for at least 2 years or not surgically s
研究者
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